Investigation of the Prevalence of Sarcopenia and Dynapenia According to Disease Stage in Patients With Multiple Sclerosis and Evaluation of the Relationship Between Sarcopenia Severity and Clinical and Functional Parameters

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorAtılım University

About this trial

This cross-sectional observational study aims to determine the prevalence of sarcopenia and dynapenia across disability stages in patients with multiple sclerosis (MS) and investigate their associations with clinical and functional parameters. Approximately 150 patients will be classified into two groups according to their Expanded Disability Status Scale (EDSS) scores: mild disability (EDSS \< 4.0) and moderate disability (EDSS 4.0-6.5). Sarcopenia and dynapenia will be assessed using the ISarcoPRM algorithm. Physical activity, fatigue, and functional independence will also be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years or older.

Diagnosed with multiple sclerosis (MS) by a neurologist.

Standardized Mini-Mental State Examination (SMMSE) score ≥24.

Expanded Disability Status Scale (EDSS) score ≤6.5.

Disqualifiers

Orthopedic surgery within the previous 3 months.

Botulinum toxin injection within the previous 3 months.

Severe cognitive impairment affecting the ability to complete assessments.

Severe cardiopulmonary disease.

Trial population

Approximately 150 adults diagnosed with multiple sclerosis (MS) receiving care at the Physiotherapy and Rehabilitation Unit of Başkent University Hospital. Participants will be classified into mild (EDSS \<4.0) and moderate (EDSS 4.0-6.5) disability groups.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Mild Disability MS
Group B: Moderate Disability MS

Trial outcomes

Primary outcomes

1

Prevalence of Sarcopenia

Sarcopenia will be classified using the ISarcoPRM algorithm based on low muscle mass (STAR) combined with reduced handgrip strength and/or physical performance. Prevalence will be calculated as the percentage of participants meeting the criteria in each EDSS group.

Time frame
Baseline
2

Prevalence of Dynapenia

Dynapenia will be defined as reduced muscle strength, independently of muscle mass, based on low handgrip strength (\<32 kg for men; \<19 kg for women) and/or prolonged five-times sit-to-stand time (≥12 seconds). Prevalence will be calculated as the percentage of participants meeting the criteria in each EDSS group.

Time frame
Baseline

Secondary outcomes

1

Handgrip Strength

Handgrip strength will be measured using a calibrated hand dynamometer. The highest value from at least two trials will be recorded in kilograms (kg).

Time frame
Baseline
2

Five-Times Sit-to-Stand Test

Participants will be asked to stand up and sit down five times without using their arms. Completion time will be recorded in seconds. A duration of 12 seconds or longer will indicate reduced physical performance.

Time frame
Baseline
3

Sonographic Thigh Adjustment Ratio (STAR)

Anterior thigh muscle thickness will be assessed using ultrasonography and adjusted for body mass index to calculate STAR. Low muscle mass will be defined as STAR \<1.0 in women and \<1.4 in men.

Time frame
Baseline
4

Sarcopenia Risk (SARC-F)

Sarcopenia risk will be assessed using the five-item SARC-F questionnaire. Total scores range from 0 to 10, with higher scores indicating greater risk. A score of 4 or higher indicates sarcopenia risk.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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Atılım University

Lead sponsor

Baskent University Ankara Hospital

Collaborator

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